15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KERATO ANALYZER (EKA)
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128855·15-20 MV FOR MEN CLSC EW STD NAVY III
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503140·Leksell MPS Arc w Counter Scale - ARC AXIS RING...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120403731·Abrasive, green, medium grit
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101819·SS Suture, 10 per sleeve
NADEEM SURGICAL CORP. PRIVATE LTD.
FDA registration
NADEEM SURGICAL CORP. PRIVATE LTD.·15 products·🇵🇰 Pakistan
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
FDA 510(k)
FDA Class 2
·General Hospital
939UDX URINE PATHOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
HEMICAP/UNICAP RESURFACING PROSTHESIS
FDA Adverse Event
Other
·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012
ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 29, 2018
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 8, 2013
SCREW
FDA Adverse Event
Malfunction
·INTERVENTIONAL SPINE, INC.·Product code MRW·February 15, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 6, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024